Devices and methods for the treatment of heart valve insufficiencies

ABSTRACT

Disclosed herein are various embodiments directed to a device for minimally invasive medical treatment. The device being a hollow tube with a first end, a second end, and one or more anchors configured to extend outward from the exterior of the hollow tube. The hollow tube having a plurality of cutouts on the exterior, wherein the cutouts allow the hollow tube to be flexible. Additionally, the hollow tube may have at least one snap mechanism configured to connect the first end and the second end together.

CROSS-REFERENCED TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 15/677,408 filed Aug. 15, 2017, entitled, “DEVICES AND METHODS FORTHE TREATMENT OF HEART VALVE INSUFFICIENCIES,” which claims benefit ofpriority under 35 U.S.C. 119(e) to the filing date of U.S. ProvisionalPatent Application 62/375,079 filed Aug. 15, 2016, entitled, “DEVICESAND METHODS FOR THE TREATMENT OF HEART VALVE INSUFFICIENCIES,” thecontents of both of which are incorporated herein by reference in theirentirety.

BACKGROUND

The present disclosure is generally related to a device for minimallyinvasive treatment of human tricuspid valve regurgitation.

Tricuspid valve regurgitation is a condition evidenced by leakiness ofthe tricuspid valve, which is the valve between the upper and lowerchambers of the right side of the heart. An individual exhibitingtricuspid valve regurgitation will have blood leak backwards through thetricuspid valve each time the right ventricle contracts. Moreparticularly, when the right ventricle contracts to pump blood towardthe lungs, some of the blood leaks backward into the right atrium. Thisincreases the volume of blood in the atrium, which can cause the rightatrium to enlarge. Enlargement of the right atrium can result in achange in the pressure in both the nearby heart chambers and adjacentblood vessels.

Functional tricuspid valve regurgitation is the most common type ofvalve pathology and is usually associated with mitral valve disease.Currently, the majority of patients with both mitral valve disease andtricuspid valve regurgitation receive surgical treatment for the mitralvalve only. Tricuspid valve regurgitation is most often under-diagnosedand/or ignored. Asymptotic dilation of the tricuspid annulus may benefitfrom repair independent of regurgitation. Without treatment fortricuspid dilation, mitral valve disease can lead to biventricularfailure and even death.

Thus, a device and method for a minimally invasive treatment of humantricuspid valve regurgitation is needed.

SUMMARY

An embodiment of a device for minimally invasive medical treatmentcomprising: a hollow tube comprising: a first end; a second end; anexterior having a plurality of cutouts, wherein the cutouts allow thehollow tube to be flexible; at least one snap mechanism configured toconnect the first end and the second end together; and one or moreanchors configured to extend outward from the exterior.

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects, features, benefits and advantages of the embodiments describedherein will be apparent with regard to the following description,appended claims, and accompanying drawings where:

FIG. 1 depicts an illustrated tricuspid valve in normal and dilatedconditions.

FIG. 2 depicts an illustrated pattern cut into a hollow tube, which isused to form a tricuspid ring.

FIG. 3 depicts another illustrated pattern cut into a hollow tube, whichis used to form a tricuspid ring.

FIG. 4 depicts the back side of the hollow tube and the pattern of thecuts for anchor deployment windows.

FIG. 5 depicts an illustrated shape of a tricuspid ring.

FIG. 6 depicts an illustrated schematic laser cut pattern.

FIG. 7 depicts an illustrated schematic laser cut tube.

FIG. 8 depicts a perspective view of an illustrated tricuspid ring withthe deployed anchors.

FIG. 9 depicts a perspective view of an illustrated tricuspid ring withzone distributions.

FIG. 10 depicts a perspective view of an illustrated laser cutfluorinated ethylene propylene (FEP) material.

FIG. 11 depicts an illustrative laser cut pattern of an FEP tube.

FIG. 12 depicts an illustrative laser cut FEP in a tubularconfiguration.

FIG. 13 depicts an illustrated geometric view of septal anchors.

FIG. 14 depicts an illustrated geometric view of posterior anchors.

FIG. 15 depicts an illustrated geometric view of anterior anchors inzone A.

FIG. 16 depicts an illustrated geometric view of anterior anchors inzone B.

FIG. 17 depicts an illustrated laser cut pattern for a posterior and/oranterior zone.

FIG. 18 depicts an illustrated laser cut pattern for a septal zone.

FIG. 19 depicts detail view of an illustrated harpoon.

FIG. 20 depicts a detail view an illustrated anchor stop feature.

FIG. 21 depicts a detail view of another illustrated anchor stop feature

FIG. 22 depicts a detail view of another illustrated anchor stopfeature.

FIG. 23 depicts a detail view of another illustrated anchor stopfeature.

FIG. 24 depicts another illustrated anchor stop feature and anillustrated harpoon.

FIG. 25 depicts a perspective view of an illustrative non-deployedanchor parked adjacent to a deployment window.

FIG. 26 depicts an illustrative view of non-deployed an anchor.

FIG. 27 depicts an illustrative view of a deployed anchor.

FIG. 28 depicts a detail view of a segment of the tricuspid ring with adeployed anchor.

FIG. 29 depicts an illustrative initial geometry of a tricuspid ring.

FIG. 30 depicts an illustrative tricuspid ring in a “D” shape geometry.

FIG. 31 depicts another illustrative tricuspid ring with a snapmechanism.

FIG. 32 depicts a detail view of an illustrative snapping mechanism in aclosed configuration.

FIG. 33 depicts a detail view of an illustrative snapping mechanism inan open configuration.

FIG. 34 depicts an isolated detail view of an illustrative snappingmechanism in a closed configuration.

FIG. 35 depicts an isolated detail view of an illustrative femalesnapping mechanism.

FIG. 36 depicts a cross-sectional view of an illustrative femalesnapping mechanism.

FIG. 37 depicts a detail view of an illustrative male snappingmechanism.

FIG. 38 depicts a view of an illustrative delivery system that isconnected to a snapped ring.

FIG. 39 depicts another view of an illustrative delivery system that isconnected to a ring with deployed anchors with the stabilizing tool inthe center.

FIG. 40 depicts an illustrative view of the delivery system.

FIG. 41 depicts another illustrative view of the delivery systemconnected to a deployed ring.

FIG. 42 depicts another illustrative view of the delivery system that isconnected to a ring.

FIG. 43 depicts another illustrative view of a hinge system associatedwith the delivery system and a stabilizing tool.

FIG. 44 depicts an illustrative view of a delivery system connected to afully deployed ring and stabilizing tool.

FIG. 45 depicts another illustrative view of a hinge system associatedwith the delivery system.

FIG. 46 depicts another illustrative view of a delivery system that isconnected to a deployed ring while being manipulated by a stabilizingtool and before anchors are deployed.

FIG. 47 depicts another illustrative view of a hinge system associatedwith the delivery system.

FIG. 48 depicts another illustrative view of a hinge system associatedwith the delivery system.

FIG. 49 depicts an illustrative view of a stabilizing tool and tricuspidring.

FIG. 50 depicts an isolated illustrative view of a stabilizing tool.

FIG. 51 depicts an illustrative view of deployed anchors at the septalzone.

FIG. 52 depicts another illustrative view of deployed anchors at theseptal and posterior zones.

FIG. 53 depicts another illustrative view of deployed anchors at theseptal zone, posterior zone, and first anterior zone.

FIG. 54 depicts another illustrative view of a stabilizing tool andtricuspid ring with deployed anchors at all zones.

FIG. 55 depicts an illustrative view of a tricuspid valve.

FIG. 56 depicts another illustrative view of a tricuspid valve.

DETAILED DESCRIPTION

This disclosure is not limited to the particular systems, devices andmethods described, as these may vary. The terminology used in thedescription is for the purpose of describing the particular versions orembodiments only, and is not intended to limit the scope.

As used in this document, the singular forms “a,” “an,” and “the”include plural references unless the context clearly dictates otherwise.Unless defined otherwise, all technical and scientific terms used hereinhave the same meanings as commonly understood by one of ordinary skillin the art. Nothing in this disclosure is to be construed as anadmission that the embodiments described in this disclosure are notentitled to antedate such disclosure by virtue of prior invention. Asused in this document, the term “comprising” means “including, but notlimited to.”

As discussed herein, the existing treatment for tricuspid valveregurgitation is invasive and potentially dangerous. For example,current treatment may include repair methods such as DeVega Repair andutilization of annuloplasty rings or tricuspid rings that require openheart surgery. Open heart surgery may introduce several comorbidities inaddition to any existing conditions. Thus, many patients who suffer fromtricuspid valve regurgitation may not be appropriate candidates for openheart surgery, and would therefore greatly benefit from a new deviceand/or method for percutaneous or minimally invasive treatment oftricuspid valve regurgitation.

An implant and delivery system for introduction of a semi-rigid ring fortreatment of tricuspid valve regurgitation includes a tricuspidannuloplasty ring comprising an outer hollow member with a plurality ofsegments. In a further embodiment, segments may be adjustable and maycooperate with one another in order to change the outer hollow memberfrom an elongated insertion shaped geometry to an annular operableshaped geometry. The tricuspid annuloplasty ring may include one or morezones comprising internal anchor members located at least partiallywithin the outer hollow member. In one non-limiting embodiment, thetricuspid annuloplasty ring may include up to four different anchorzones, which are further discussed herein. In an embodiment, theinternal anchor members may be configured to emerge sequentially fromwindows (i.e., openings) along the hollow tube, thereby engaging thetissue of the tricuspid valve annulus under treatment, potentially in apredetermined sequence.

Disclosed herein are various embodiments related to minimally invasiveor percutaneous trans-catheter delivery of a tricuspid ring. Inaddition, an embodiment may comprise methods for reducing or adjustingthe dimension between the anterior and septal leaflets and/or reducingor adjusting the dimension between the anteroposterior commissure toseptal leaflet, thereby minimizing or eliminating the issue of tricuspidvalve regurgitation.

The illustrated example embodiments will be best understood by referenceto the figures. The following description is intended only by way ofexample, and simply illustrates certain example embodiments.

Referring to FIG. 1 , a perspective view of a tricuspid valve 100, as itrelates to various embodiments discussed herein, is shown. As shown, inan embodiment, the tricuspid valve 100 may have an anterior-septaldirection and an anterior-posterior to septal leaflet direction.Additionally, FIG. 1 illustrates an outline of a normal sized annulus101, a dilated annulus 102, a desired shape of a tricuspid ring 103, andan Atrioventricular (AV) node 104. FIG. 1 further shows the annularreduction directions (i.e., the plurality of arrows 105) that may berequired to reduce tricuspid valve regurgitation.

As would be understood by one skilled in the art, the AV node 104 is apart of the electrical conduction system of the heart that coordinatesthe top of the heart. The AV node 104 is an area of specialized tissuebetween the atria and the ventricles of the heart, specifically in theposteroinferior region of the interatrial septum near the opening of thecoronary sinus, which conducts the normal electrical impulse from theatria to the ventricles. Puncturing or introducing any impulse into thisnode causes adverse effects such as Arrhythmia, irregular heart rhythm,and, in the worst, case heart failure. Therefore, in an embodiment, thedesign of a tricuspid ring may not include anchors in the segment of thering that will be located adjacent to the AV node.

In FIGS. 2 and 3 , a perspective view of an illustrative embodiment mayinclude a hollow tube 201/301, which may be made of various materials(e.g., a shape memory hypotube (nickel titanium (Ni—Ti) super elasticalloy)) cut to form a plurality of segments 202/302. In one embodiment,the cuts 203/303 in the hollow tube may allow for the tube to be used asan outer tube of a segmented tricuspid annuloplasty ring. Additionally,FIG. 4 shows an illustrative schematic diagram further detailing thecutting pattern used for laser processing (e.g., the cutting of windows402 through which anchors (not shown) may be deployed) of the hypo tube401 as illustrated in FIGS. 2 and 3 .

In an embodiment, as shown by the schematic diagram in FIG. 5 , theshape of the memory hypotube 501, as discussed and shown in FIGS. 2 and3 , may have an operable geometry. For example, the hypotube may beannular and/or D shaped (as shown in FIG. 5 ). Furthermore, anembodiment may, as shown, comprise a delivery system interface point502.

Referring now to FIG. 6 , a schematic laser cut pattern 600 for use inlaser processing is shown. In one embodiment, the laser cut pattern 100may integrate a plurality of segments (e.g., the windows for the anchorsand the specific attachment holes for additional members. In oneembodiment, a closing feature(s) may utilize the specific attachmentholes in order to secure a connection and close the tricuspid ring.Thus, as shown in FIG. 6 , an illustrative embodiment may include one ormore laser cut patterns 600, one or more laser cut slots for flexibility601, one or more windows for anchors 602, one or more windows forsutures 603, one or more holes for fabric attachment and fluorinatedethylene propylene (FEP) attachment 604, one or more holes for a suturepin 605, and one or more snap features for the suture pin 606.

Fluorinated ethylene propylene or FEP is a copolymer ofhexafluoropropylene and tetrafluoroethylene. It differs frompolytetrafluoroethylene resins in that it is melt-processable usingconventional injection molding and screw extrusion techniques. Moreover,it has a very low coefficient of friction and thus, in an embodiment,may make an exceptional material to serve as an anchor track and/oranchor the assemblies within the laser cut Ni—Ti rings. FEP providesvarious benefits over current methods, such require a significantpulling force to retrieve a metal end of a metal ring, particularly onethat has a bend radius, after deployment from a catheter. In contrast,an embodiment may utilize an FEP tube that is laser cut and allows easysliding of the anchor assembly within the laser cut Ni—Ti ring.

FEP is very similar in composition to the fluoropolymers PTFE(polytetrafluoroethylene) and PFA (perfluoroalkoxy polymer resin). FEPand PFA both share PTFE's useful properties of low friction andnon-reactivity, but are more easily formable. FEP is softer than PTFEand melts at 260° C. It is also highly transparent and resistant tosunlight.

As shown in FIG. 7 , a further embodiment may include a schematic lasercut tube 700. In one embodiment, the schematic laser cut tube 700configuration may integrate a plurality of segments (e.g., the windowsfor the anchors and the specific attachment holes for additional memberssuch as a closing feature(s) to close the tricuspid ring). Thus, asshown in FIG. 7 , an illustrative embodiment may include one or morelaser cut slots for flexibility 701, one or more windows for anchors702, one or more windows for sutures 703, one or more holes for fabricand FEP attachment 704, one or more holes for a suture pin 705, and asnap feature for the suture pin 706.

Referring now to FIG. 8 , a perspective view of an illustrativeembodiment is shown including a tricuspid annuloplasty ring 800 withfour zones of internal anchors being deployed. Specifically, anembodiment may have a first anterior anchoring zone 801, a second ananterior anchoring zone 802, a posterior anchoring zone 803, a septalanchoring zone 804, and an AV node 805. In some embodiments, the AV nodemay comprise no anchors.

Additionally or alternatively, FIG. 9 illustrates alternative zonedistributions in a tricuspid ring. In this configuration, the septalzones may overlap and thus create an improved attachment to the septalannulus. As shown in FIG. 9 , an illustrative embodiment may include atricuspid ring with four zones of anchors 900, an outer ring 901, afirst septal zone 902, a second septal zone 903, a posterior zone 904,and an anterior zone 905, a snapping/closure mechanism 906, and a pivotpin attachment point 907, wherein the pivot pin attachment pointattaches to a snapping mechanism of a delivery system.

Referring now to FIG. 10 , a perspective view of a laser cut FEP 1001that is used as a lining for the inside diameter of the hollow laser cuttube is shown. In one embodiment, the laser cut FEP may include lasercut anchor deployment windows 1002 that correspond to the laser cutwindows on the hollow segmented tube (i.e., 700 shown in FIG. 7 ).Additionally, an embodiment may, as shown in FIG. 11 , include a lasercut pattern 1100 for the FEP to enable it to properly line the insidediameter of the hollow laser cut tube. Moreover, as shown in FIG. 11 ,the laser cut pattern may include laser cut windows 1103 that correspondto laser cut windows on the hollow segmented tube, wherein both patternsallow for the flexibility of the FEP tube to bend along with the outerring. As shown in FIG. 11 , an illustrative embodiment may include alaser cut FEP 1100, a material release to allow flexibility 1101, one ormore corresponding holes for sutures and coding of the FEP to the ringtube 1102, and one or more corresponding windows for the anchors 1103.

FIG. 12 shows an alternate perspective view of an embodiment including alaser cut FEP in its tubular configuration 1200. As shown, the laser cutFEP 1200 may provide a lining for the inside diameter of the hollowlaser cut tube, and include one or more laser cut windows thatcorrespond to one or more laser cut windows 1203 on the hollow segmentedtube, as discussed herein. A further embodiment may have a pattern thatallows the FEP tube 1200 to be flexible and bend with the outer ring,such as that shown in FIG. 12 . As shown in FIG. 12 , an embodiment mayinclude a laser cut FEP 1200, a material release to allow flexibility1201, one or more corresponding holes for sutures and coding of the FEPto the tricuspid ring tube 1202, and one or more corresponding windows1203 for the anchors.

Referring to FIGS. 13-16 , embodiments are shown that illustrate thegeometry and view of four anchor rails. For example, FIG. 13 depicts theanchor rail for the septal zone of the tricuspid ring and FIG. 14depicts the anchor rail for the posterior leaflet. FIGS. 15 and 16depict two anchor rails which are each designed to anchor the tricuspidring to the anterior section of the tricuspid valve (e.g., Zone A andZone B of the anterior section).

A further embodiment, as illustrated in FIG. 17 , may have an anchorsystem for a posterior/anterior zone. By way of non-limiting example, anillustrative embodiment, such as is shown in FIG. 17 , may include ananchor zone 1700, a harpoon 1702, a harpoon barb 1703 an anchor stop(AS) feature 1704, an anchor zone rail 1706, an anchor zone deploymenthole 1719, and a loading hole 1720.

As discussed herein, various embodiments may employ an anchor stop(e.g., 1704). The need for an anchor stop arises from the fact that theanchors may move after a tricuspid ring is deployed from the catheter(e.g., in linear shape) and takes on the “D” shape, as discussed herein.Specifically, the anchor assemblies that were held stationary when thering was held in a linear position (e.g., the anchors held beneath andadjacent to the windows in the laser cut tube) may start moving andemitting prematurely from the windows because of the bend radius of thering.

Thus, in order to combat premature deployment, which may render the ringuseless and cause serious issues during the procedure, an embodimentutilizes the anchor stops to hold the anchors in place until the ringhas reached its final location and deployment is appropriate. Once theassembly has reached its final location, the anchor stop may be overcomewhen an operator pulls a suture that is connected to the anchor assemblyand forces the assembly and its stopper to slide, thus deploying theanchor systems, in the method discussed herein. Generally, an anchorstop is a bump geometrical feature, or step that prevents the anchorassembly from moving when the ring is deployed out of the deliverysystem; however, various embodiments and configurations are discussedherein and shown in the corresponding figures.

In another embodiment, illustrated in FIG. 18 , a laser cut pattern maybe used for a septal zone. As shown in FIG. 18 , an embodiment mayinclude an anchor zone 1800, a harpoon 1801, a harpoon barb 1802, ananchor stop (AS) feature 1803, an anchor zone rail 1804, an anchor zonedeployment hole 1819, and a loading zone 1820. Additional detailregarding the harpoon 1801 is shown in FIG. 19 . As illustrated by theembodiment in FIG. 19 , the harpoon 1801 may have one or more harpoonbarbs 1902. Additional detail regarding the anchor stop feature 1803 isshown in FIG. 20 . As illustrated by the embodiment in FIG. 20 , theanchor stop feature 1803 may include a first connecting strut 2011, asecond connecting strut 2012, a deployment angle 2013, and an anchorstop feature height 2014.

Additionally or alternatively, as shown in FIG. 21 , an embodiment mayinclude an anchor stop feature 1803 attached with one strut to an anchorzone having a negative deployment angle 2113. In a further embodiment,the anchor stop feature 1803 may include one or more deployment holes2115. Thus, as illustrated in FIG. 21 , an embodiment may include atypical anchor stop feature 1803, a first connecting strut 2111, adeployment angle 2113, an anchor stop feature height 2114, an anchorstop deployment hole 2115, and an anchor zone suture routing hole 2118.

FIG. 22 depicts another illustrative embodiment of an anchor stopfeature 1803. As shown, the anchor stop feature 1803 may include a firstconnecting strut 2211, a second connecting strut 2212, a deploymentangle 2213, and an anchor stop feature height 2214. Additionally oralternatively an embodiment, as shown in FIG. 23 , may include an anchorstop feature 1803 with a weak point 2216 to direct an anchor stopdisconnection at a certain point. Thus, an embodiment, as shown in FIG.23 , may include a first connecting strut 2311, a deployment angle 2313,an anchor stop feature height 2314, an anchor stop deployment hole 2315,and a weak point of the anchor stop feature strut 2316.

Referring now to FIG. 24 , an embodiment may include an active anchorstop feature with activation holes 2417 on the anchor zone rail. Thus,as shown in FIG. 24 , an illustrated embodiment may include a firstconnecting strut 2411, a deployment angle 2413, an anchor stop featuredeployment hole 2415, an activation hole 2417 for transforming thesuture direction from horizontal to vertical, an anchor zone suturerouting hole 2418, and an anchor zone deployment hole 2419.

As discussed herein, an embodiment may take the shape of the memoryhypotube and may have an operable geometry, for example, an annularand/or D shaped geometry (as shown in FIG. 5 ). Referring now to FIG. 25, a perspective view of an illustrative distal end of a delivery system2501 with an implant interface member connected to the tricuspid ring2502 is shown.

FIGS. 26 and 27 illustrate a general view of one or more typical anchorsin an initial and deployed position, respectively. In FIG. 26 , theanchor 2601 is tucked within the hollow laser cut tube 2602 under itsrespective deployment window. In FIG. 27 , a non-limiting illustrationshows a deployed anchor 2701 after it has been deployed from itsrespective deployment window 2702. Further detail of a deployed anchor2701 is shown in FIG. 28 , which depicts a magnified view of a segmentof the tricuspid ring 2803 that includes a deployment window 2802 (seealso 602 of FIG. 6 ) and a deployment anchor 2801.

Referring now to FIG. 29 , an embodiment is depicted that includes aninitial geometry of the tricuspid ring when deployed from the deliverysystem (e.g., the solid lines) and the geometry of the tricuspid ringafter deployment of all anchors (e.g., the dashed lines). In someembodiments the tricuspid ring may comprise a first anterior zone, asecond anterior zone, a posterior zone, and a septal zone. Thus, asshown in FIG. 29 , the solid lines may depict the initially deployedgeometry, while the dashed lines may depict one possible final geometryafter the anterior leaflet (e.g., at zone 2) has been transferred toreduce the anterior septal height.

FIG. 30 shows a perspective view of an embodiment wherein a tricuspidring 3000 may include one or more snap mechanisms 3001 that connect aproximal and distal end of the laser cut hollow tube to create ageometric shape (e.g., a “D” shape). In a further embodiment, thegeometrically shaped tricuspid ring may include one or more anchors 3002which can be deployed from the deployment windows 3003.

FIG. 31 shows a perspective view of an embodiment wherein a tricuspidring 3100 includes a snap mechanism 3105 that connects a proximal and adistal end of the laser cut hollow tube (700 of FIG. 7 ) to create ashape that mimics the native shape of the tricuspid annulus. In afurther embodiment, the tricuspid ring 3100 may also include one or moreanchors deployed from the one or more deployment windows. In oneembodiment, as shown in FIG. 31 , the anchors may exit from thedeployment windows at an angle within a range of about 30 degrees to thehorizontal plane to about 75 degrees to the horizontal plane.

Thus, as shown in FIG. 31 , an embodiment may include a tricuspid ring3100, an anterior zone 3101 where the anchors exit from the tricuspidring at an angle to provide anchoring forces in both the radial andaxial directions, a posterior zone 3102 where the anchors exit from thetricuspid ring at an angle to provide anchoring forces in both theradial and axial directions, a first septal zone 3103 where the anchorsexit the ring at an angle to provide anchoring forces in both the radialand axial directions, a second septal zone 3104 where the anchors exitfrom the ring at an angle to provide anchoring forces in both the radialand axial directions, a snapping mechanism (e.g., closure mechanism)3105, and a suture pin to provide a rotational pin for the sutures 3106.

FIG. 32 shows a perspective view of an embodiment wherein a snappingmechanism 3200 is utilized to secure the tricuspid ring in a closedconfiguration. Thus, as shown in FIG. 32 , an embodiment may include asnapping mechanism 3200, a suture pin (e.g., attachment of female andmale parts of the ring tube) 3201, a female part of the snappingmechanism 3202, a pivot pin (e.g., attachment of the snapping mechanismto the delivery system with a safety wire) 3203, a cover part (e.g., acomponent to hold the nitinol disk that snaps the male part into thefemale) 3204, and a male part of the snapping mechanism 3205.

FIG. 33 shows a detailed view of an embodiment, wherein the snappingmechanism 3300 is in an open configuration. Again, similar toembodiments discussed herein, the snapping mechanism 3300 is utilized tosecure the tricuspid ring in a closed configuration. Thus, as shown inFIG. 33 , an embodiment may include a snapping mechanism 3300, a femalepart of the snapping mechanism 3301, a pivot pin (e.g., attachment ofthe snapping mechanism to the delivery system with a safety wire) 3302,a cover part (e.g., a component to hold the Nitinol disk that snaps themale part into the female) 3303, a cup (e.g., an interface of the femaleto the ring tube) 3304, and a male part of the snapping mechanism 3305.

A detailed view of an embodiment where the snapping mechanism is in aclosed configuration is shown in FIG. 34 . Similar to embodimentsdiscussed herein, the snapping mechanism 3400 is utilized to secure thetricuspid ring in a closed configuration. Thus, as shown in FIG. 34 , anembodiment may include a snapping mechanism 3400, a female part of thesnapping mechanism 3401, a pivot pin (e.g., attachment of the snappingmechanism to the delivery system with a safety wire) 3402, a cover part(e.g., part to hold the Nitinol disk that snaps the male part into thefemale) 3403, a cup (e.g., an interface of the female to the ring tube)3404, and a male part of the snapping mechanism 3405.

A detailed view of the female part 3401 of the snapping mechanism 3400according to one embodiment is shown in FIG. 35 . As shown in FIG. 35 ,the female part 3401 of the snapping mechanism 3400 may include, a pivotpin (e.g., an attachment of the snapping mechanism to the deliverysystem with a safety wire) 3502, a cup (e.g., an interface of the femaleto the ring tube) 3503, a nitinol disk for locking the snap intoposition 3504, a window for suture routing 3505, a window for a suturepin 3506, and a gold marker 3507.

FIG. 36 shows an illustrative cross section of the female part 3401 ofthe snapping mechanism 3400 according to an embodiment. As shown in FIG.36 , the female part 3401 of the snapping mechanism 3400 may include apivot pin (e.g., an attachment of the snapping mechanism to the deliverysystem with a safety wire) (not shown), a cover that holds a nickeltitanium (Ni—Ti) disk 3602, a cup (e.g., an interface of the female tothe ring tube) 3603, a nitinol disk for locking the snap into position(tongues can open only in one direction to prevent un-intentionalunsnapping) 3604, a window for suture routing 3605, and a window for asuture pin 3606.

A detailed view of the male part 3405 of the snapping mechanismaccording to an embodiment is shown in FIG. 37 . As shown in FIG. 37 ,the male part 3405 of the snapping mechanism 3400 may include a malecone 3701 to allow smooth entrance and locking of the male within thefemale, a least one window for suture routing 3702, at least one windowfor a suture pin 3703, and at least one protrusion 3704 upon the suturepin.

Turning now to FIG. 38 , a detailed view of a distal end of a deliverysystem is shown. In one embodiment, the distal end of the deliverysystem may interface with the tricuspid ring assembly. For example, FIG.39 illustrates a detailed view of the distal end 3901 of the deliverysystem 3900, wherein the delivery system interfaces with the tricuspidring assembly and the tricuspid ring 3950.

As shown in FIG. 39 , the delivery system 3900 may interface with atricuspid ring 3950 that may have an anterior zone 3951 where anchorsexit the ring at an angle to provide anchoring forces in both the radialand axial direction. The tricuspid ring 3950 may also have a posteriorzone 3952 where anchors exit the tricuspid ring at an angle to provideanchoring forces in both the radial and axial direction, a snappingmechanism (e.g., closure mechanism) 3953, and a suture pin to provide arotation pin for the sutures 3954. the delivery system 3900 may includea distal end of the guiding catheter 3901, a stabilizing mechanism toensure ring stabilization during an implantation procedure 3902, adelivery system (DS) tongue (e.g., ring interface device) 3903, and astabilizing tool 3904.

FIGS. 40-42 depict various views of the delivery system during thebeginning of the deployment of the tricuspid ring from the deliverysystem. In one embodiment, and as shown in FIG. 40 , the tricuspid ring4001 may exit the delivery system 4002 in a linear shape. Once thetricuspid ring 4001 exits the delivery system, it may in someembodiments be formed into a ring-like shape using methods disclosedherein, and as shown in FIGS. 41 and 42 . FIG. 41 shows an embodiment inwhich the tricuspid ring 4101 is formed using the delivery system 4102.In some embodiments, and as shown in FIG. 41 , the tricuspid ring 4101may be between about 30° and about 40° from a plane normal to thedelivery system 4102. FIG. 42 shows an embodiment in which the tricuspidring 4201 is formed and the snapping mechanism (e.g., closure mechanism)4203 secures the ring in the proper geometry. In some embodiments, suchas that shown in FIG. 42 , the delivery system 4202 may be used to moveor modify the shape or location of the tricuspid ring 4201.

In some embodiments, such as that shown in FIG. 43 , the delivery system4300 may interface with a tricuspid ring 4350. The tricuspid ring 4350may also have a posterior zone where anchors exit the tricuspid ring(not shown) at an angle to provide anchoring forces in both the radialand axial direction, a snapping mechanism (e.g., closure mechanism) (notshown), and a suture pin to provide rotation pin for the sutures (notshown). The delivery system 4300 may include a distal end of the guidingcatheter (not shown), a stabilizing mechanism 4301 to ensure ringstabilization during an implantation procedure, a delivery system (DS)tongue (e.g., ring interface device) (not shown), and a stabilizing tool4302. As shown, the plane of the tricuspid ring 4350 may be betweenabout 0° and about 40° removed from the plane of the tricuspid valveafter rotation around the hinge.

In another embodiment, as shown in FIG. 44 , the plane of the ring maybe parallel or slightly angled (e.g., from about 0° to about 40°) to theplane of the tricuspid valve after rotation around the hinge. Thus, anembodiment may utilize a trans-apical approach (i.e., pulling the ringto the tissue). In some embodiments, the delivery system 4400 mayinterface with a tricuspid ring 4450 that may have an anterior zonewhere anchors (not shown) exit the ring at an angle to provide anchoringforces in both the radial and axial direction. The tricuspid ring 4450may also have a posterior zone 4403 where anchors exit the tricuspidring at an angle to provide anchoring forces in both the radial andaxial direction, a snapping mechanism (e.g., closure mechanism) (notshown), and a suture pin to provide a rotation pin for the sutures (notshown). The delivery system 4400 may include a distal end of the guidingcatheter 4401, a stabilizing mechanism 4402 to ensure ring stabilizationduring an implantation procedure, a delivery system (DS) tongue (e.g.,ring interface device) (not shown), and a stabilizing tool 4404. Asstated, the ring orientation in relation to the delivery system 4400 maybe in a range of about 0 degrees to about 40 degrees “above” thehorizontal plane. As discussed herein, this approach is trans-apical,thus pulling the ring to the tissue. In a further embodiment, the ringorientation may be in a range of about 0 degrees to about 40 degrees“above” the horizontal plane of the delivery system. FIG. 44 depicts theembodiment of FIG. 43 with the anchors deployed.

In another embodiment, as shown in FIG. 45 , the position of thetricuspid ring may be parallel to or below the plane of the tricuspidvalve after rotation around the hinge. Again this approach istrans-apical, thus pulling the ring to the tissue. However, FIG. 45differs from the embodiment of FIGS. 43-44 , in that the ringorientation in relation to the delivery system may be in a range ofabout 0 degrees to about 40 degrees “below” the horizontal plane. In anadditional embodiment, as shown in FIG. 45 , the position of thetricuspid ring after rotation around the hinge may be parallel orslightly below to the plane of the tricuspid valve. The ringorientation, in this embodiment, in relation to the delivery system maybe in a range of about 0 degrees to about 40 degrees “below” thehorizontal plane. FIG. 46 depicts an embodiment with the anchorsdeployed.

As shown in FIGS. 45-46 , in some embodiments, the delivery system4500/4600 may interface with a tricuspid ring 4550 that may have ananterior zone where anchors (not shown) exit the ring at an angle toprovide anchoring forces in both the radial and axial direction. Thetricuspid ring 4550 may also have a posterior zone where anchors exitthe tricuspid ring at an angle to provide anchoring forces in both theradial and axial direction, a snapping mechanism (e.g., closuremechanism) (not shown), and a suture pin to provide a rotation pin forthe sutures (not shown). The delivery system 4500 may include a distalend of the guiding catheter 4501, a stabilizing mechanism to ensure ringstabilization during an implantation procedure 4502, a delivery system(DS) tongue (e.g., ring interface device) (not shown), and a stabilizingtool 4504.

FIG. 47 shows a zoomed in view of the tricuspid ring 4750 after rotationaround the hinge whereby the plane of the ring may be parallel to theplane of the tricuspid valve. The approach may be trans-atrial,trans-septal, and/or trans-jugular, thus pulling the ring to the tissue.In an embodiment, as shown in FIG. 47 , the ring orientation in relationto the delivery system may be in a range of about 0 degrees to about 40degrees “below” the horizontal plane, and the anchors may or may not bedeployed.

Additionally or alternatively, FIG. 48 shows a zoomed in view of thetricuspid ring 4850 after rotation around the hinge whereby the plane ofthe ring is parallel to the plane of the tricuspid valve. The approachof FIG. 48 may also be trans-atrial, trans-septal, and/or trans-jugular,thus pulling the ring to the tissue. In another embodiment, as shown inFIG. 48 , the ring orientation in relation to the delivery system may bein a range of about 0 degrees to about 40 degrees “above” the horizontalplane, and the anchors 4751 may or may not be deployed.

Referring now to FIGS. 49-50 , an embodiment shows the geometry of thestabilizing tool that may be needed for the placement of the tricuspidring 4901 above the annulus. By way of non-limiting example, FIG. 49shows the tricuspid ring 4901, which may comprise various zones, and itsinteraction with the stabilizing tool 4902. In one embodiment, thestabilizing tool 4902 may be incorporated or attached to the deliverysystem 4903, as shown in FIG. 49 . A more detailed view of thestabilizing tool is shown in FIG. 50 . In some embodiments, thestabilizing tool 5001 may be made of super elastic nickel titanium(Ni—Ti) from a laser cut hypotube.

FIGS. 51-54 depict an illustrative ring as it is placed in the annulus,and the deployment of the anchors into the tricuspid annulus. Inparticular, FIG. 51 depicts the deployment of the septal anchors intothe septal section of the tricuspid annulus adjacent to the septalleaflet. Additionally, FIG. 52 shows the deployment of the posterioranchors into the posterior section of the annulus adjacent to theposterior leaflet. FIG. 53 shows the additional deployment of the firstzone of the anterior anchors that are adjacent to the anterior leaflet.FIG. 54 shows dragging of the anterior leaflet (e.g., by the stabilizingtool) as a means to reduce the dilation of the annulus and as aconsequence, improve the coaptation of the anterior leaflet and theseptal leaflet.

FIGS. 55-56 shows further illustrative embodiments of a tricuspid valve5500/5600. With reference to FIG. 55 , it should be understood that atricuspid valve 5500 may include: an anteroseptal commissure 5501, aseptal leaflet 5502, an anteroposterior commissure 5503, an anteriorleaflet 5504, a posteroseptal commissure 5505, an annulus 5506, acoronary sinus 5507, and an AV node 5508. As shown in FIG. 56 , theannulus of tricuspid valve 5600 may be dilated. A dilated annulus shape5601 is shown alongside a normal sized annulus (i.e., the desired shapeif a tricuspid ring) 5602 (dashed lines) as a non-limiting example forclarity purposes. The tricuspid valve 5600 may also include an AV node5608.

Accordingly, systems and methods are provided for introducing atricuspid ring (e.g. while it is housed in a linear shape within thedelivery system) in a trans-apical or trans-femoral approach. In anembodiment, the distal tip of the delivery system may be introducedabove the tricuspid annulus. Once the tricuspid ring is introduced, theplane of the tricuspid ring may be rotated (e.g., automatically) to beparallel to the plane of the tricuspid annulus.

The tricuspid ring may then be snapped into a proper shape (e.g., a “D”shape) and introduced to the stabilization tool. The shape is possiblebecause, as discussed herein, the tricuspid ring comprises an outerhollow member with a plurality of segments, wherein the segments may beadjustable and may cooperate with one another in order to change theouter hollow member from an annular operable shaped geometry to anelongated insertion shaped geometry and vice versa.

Once the tricuspid ring is properly controlled by the stabilization tool(e.g., as depicted in FIGS. 38-54 ), the properly shaped (e.g., “D”shaped) tricuspid ring may be inserted and guided to the desiredlocation within the patient (e.g., the tricuspid valve). Once in theproper location, an embodiment may deploy a plurality of anchors. Forexample, an embodiment may deploy anchors associated with the septalzone, the posterior zone, or the first or second anterior zones.

In a further embodiment, the anchored tricuspid ring is anchored towardsthe septal leaflet, thereby reducing the height of the anterior-septalleaflets by approximately 15% to 20%. One or more second anterior zoneanchors may also be deployed. In another embodiment, the design of thetricuspid ring may not include anchors in certain zones (e.g., the AVnode zone). As discussed herein, this may be due to a particular zonebeing sensitive to external forces which could lead to adverse effectsfor the patient such as Arrhythmia, an irregular heart rhythm or heartfailure.

Additionally or alternatively, the tricuspid ring (e.g., the septal zoneand the posterior zone) may be dragged by the stabilizing tool to reducethe height of the anterior-septal leaflet height prior to the anchors inthe first and second anterior zones one and two being applied.

In the above detailed description, reference is made to the accompanyingdrawings, which form a part hereof. In the drawings, similar symbolstypically identify similar components, unless context dictatesotherwise. The illustrative embodiments described in the detaileddescription, drawings, and claims are not meant to be limiting. Otherembodiments may be used, and other changes may be made, withoutdeparting from the spirit or scope of the subject matter presentedherein. It will be readily understood that the aspects of the presentdisclosure, as generally described herein, and illustrated in theFigures, can be arranged, substituted, combined, separated, and designedin a wide variety of different configurations, all of which areexplicitly contemplated herein.

The present disclosure is not to be limited in terms of the particularembodiments described in this application, which are intended asillustrations of various aspects. Many modifications and variations canbe made without departing from its spirit and scope, as will be apparentto those skilled in the art. Functionally equivalent methods andapparatuses within the scope of the disclosure, in addition to thoseenumerated herein, will be apparent to those skilled in the art from theforegoing descriptions. Such modifications and variations are intendedto fall within the scope of the appended claims. The present disclosureis to be limited only by the terms of the appended claims, along withthe full scope of equivalents to which such claims are entitled. It isto be understood that this disclosure is not limited to particularmethods, reagents, compounds, compositions or biological systems, whichcan, of course, vary. It is also to be understood that the terminologyused herein is for the purpose of describing particular embodimentsonly, and is not intended to be limiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (for example, bodiesof the appended claims) are generally intended as “open” terms (forexample, the term “including” should be interpreted as “including butnot limited to,” the term “having” should be interpreted as “having atleast,” the term “includes” should be interpreted as “includes but isnot limited to,” et cetera). While various compositions, methods, anddevices are described in terms of “comprising” various components orsteps (interpreted as meaning “including, but not limited to”), thecompositions, methods, and devices can also “consist essentially of” or“consist of” the various components and steps, and such terminologyshould be interpreted as defining essentially closed-member groups. Itwill be further understood by those within the art that if a specificnumber of an introduced claim recitation is intended, such an intentwill be explicitly recited in the claim, and in the absence of suchrecitation no such intent is present.

For example, as an aid to understanding, the following appended claimsmay contain usage of the introductory phrases “at least one” and “one ormore” to introduce claim recitations. However, the use of such phrasesshould not be construed to imply that the introduction of a claimrecitation by the indefinite articles “a” or “an” limits any particularclaim containing such introduced claim recitation to embodimentscontaining only one such recitation, even when the same claim includesthe introductory phrases “one or more” or “at least one” and indefinitearticles such as “a” or “an” (for example, “a” and/or “an” should beinterpreted to mean “at least one” or “one or more”); the same holdstrue for the use of definite articles used to introduce claimrecitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should be interpreted to mean at least the recited number(for example, the bare recitation of “two recitations,” without othermodifiers, means at least two recitations, or two or more recitations).Furthermore, in those instances where a convention analogous to “atleast one of A, B, and C, et cetera” is used, in general such aconstruction is intended in the sense one having skill in the art wouldunderstand the convention (for example, “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, et cetera). In those instanceswhere a convention analogous to “at least one of A, B, or C, et cetera”is used, in general such a construction is intended in the sense onehaving skill in the art would understand the convention (for example, “asystem having at least one of A, B, or C” would include but not belimited to systems that have A alone, B alone, C alone, A and Btogether, A and C together, B and C together, and/or A, B, and Ctogether, et cetera). It will be further understood by those within theart that virtually any disjunctive word and/or phrase presenting two ormore alternative terms, whether in the description, claims, or drawings,should be understood to contemplate the possibilities of including oneof the terms, either of the terms, or both terms. For example, thephrase “A or B” will be understood to include the possibilities of “A”or “B” or “A and B.”

In addition, where features or aspects of the disclosure are describedin terms of Markush groups, those skilled in the art will recognize thatthe disclosure is also thereby described in terms of any individualmember or subgroup of members of the Markush group.

As will be understood by one skilled in the art, for any and allpurposes, such as in terms of providing a written description, allranges disclosed herein also encompass any and all possible subrangesand combinations of subranges thereof. Any listed range can be easilyrecognized as sufficiently describing and enabling the same range beingbroken down into at least equal halves, thirds, quarters, fifths,tenths, et cetera. As a non-limiting example, each range discussedherein can be readily broken down into a lower third, middle third andupper third, et cetera. As will also be understood by one skilled in theart all language such as “up to,” “at least,” and the like include thenumber recited and refer to ranges that can be subsequently broken downinto subranges as discussed above. Finally, as will be understood by oneskilled in the art, a range includes each individual member. Thus, forexample, a group having 1-3 cells refers to groups having 1, 2, or 3cells. Similarly, a group having 1-5 cells refers to groups having 1, 2,3, 4, or 5 cells, and so forth.

Various of the above-disclosed and other features and functions, oralternatives thereof, may be combined into many other different systemsor applications. Various presently unforeseen or unanticipatedalternatives, modifications, variations or improvements therein may besubsequently made by those skilled in the art, each of which is alsointended to be encompassed by the disclosed embodiments.

What is claimed is:
 1. A method of delivering an annuloplasty ringcomprising: delivering the annuloplasty ring in a linear shape using adelivery system, wherein the delivery of the annuloplasty ring utilizesat least one of a trans-femoral approach, a transapical approach, atrans-jugular approach, and a trans-atrial approach; assuming a desiredpositioning of the annuloplasty ring by rotating the annuloplasty ringaround a hinge until the annuloplasty ring is parallel to a plane of anannulus; and activating one or more anchor rails, each with a pluralityof anchors, to extend the plurality of anchors outward from theannuloplasty ring, wherein the one or more anchor rails each comprise ananchor stop mechanism that comprises a projection that projects apredetermined height from the anchor rail to hold the plurality ofanchors in place during assuming the desired position of theannuloplasty ring, and wherein the anchor stop mechanism preventspremature deployment of the plurality of anchors until the anchor stopmechanism is overcome by activating the one or more anchors rails. 2.The method of claim 1, further comprising shaping the annuloplasty ringusing a stabilizing tool prior to delivery.
 3. The method of claim 2,wherein the shaping further comprises reducing the height of theannuloplasty ring.
 4. The method of claim 3, wherein the height isreduced by approximately 15% to 20%.
 5. The method of claim 1, whereinactivating the plurality of anchors to extend outward is based on one ormore predefined zones on the annuloplasty ring.
 6. The method of claim1, wherein there are no anchors within a section of the ring that willbe installed into the annulus section that is adjacent to a patient's AVnode.
 7. The method of claim 1, wherein the annuloplasty ring isimplanted at a tricuspid valve of a patient.